Improving Exercise Rehabilitation Efficacy Outcomes Veterans Peripheral Artery Disease
Reason given: Inadequate participant recruitment
Key facts
- Where
- Salt Lake City, United StatesSee the 2 sites
Where in United States
- University of Utah Dept of Vascular SurgerySalt Lake City, United StatesNo longer taking part
- VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake City, United StatesNo longer taking part
Trial details
- Who runs it
- VA Office of Research and Development
- Trial code
- NCT05648630
- Record updated
- 10 November 2025
- Original description
Physical activity is the most beneficial and cost-effective treatment for Veterans with PAD, however, issues with oxygen delivery and utilization dramatically impair exercise compliance. The cause of these oxygen delivery and utilization impairments is likely increased oxidative stress and inflammation. The proposed project will comprehensively examine the novel strategy of Nuclear Factor Erythroid-2-like 2 (Nrf2) activation using PB125, aimed at diminishing oxidative stress and inflammation, and thereby lessening the negative impacts of the disease. This therapeutic will be evaluated in isolation and in combination with exercise rehabilitation to determine if there is a complimentary benefit. The ultimate goal is to provide insight into a potential novel therapeutic treatment for this disease, therefore, improving exercise tolerance and quality of life in this growing population.Read full original descriptionShow less
Improving Exercise Rehabilitation Efficacy and Outcomes in Veterans With Peripheral Artery Disease: Targeting Oxidative Stress and Inflammation
Physical activity is the most beneficial and cost-effective treatment for Veterans with PAD, however, issues with oxygen delivery and utilization dramatically impair exercise compliance. The cause of these oxygen delivery and utilization impairments is likely increased oxidative stress and inflammation. The proposed project will comprehensively examine the novel strategy of Nuclear Factor Erythroid-2-like 2 (Nrf2) activation using PB125, aimed at diminishing oxidative stress and inflammation, and thereby lessening the negative impacts of the disease. This therapeutic will be evaluated in isolation and in combination with exercise rehabilitation to determine if there is a complimentary benefit. The ultimate goal is to provide insight into a potential novel therapeutic treatment for this disease, therefore, improving exercise tolerance and quality of life in this growing population.
Inclusion: Age 40 and older with clinically diagnosed femoropopliteal PAD (ankle-brachial index < 0.9); Must understand the study requirements and be willing and able to sign an informed consent document; Patients with mild cognitive impairment (i.e., montreal cognitive assessment (MOCA) <26) will be included but must have a responsible caregiver or spouse present during the informed consent; Women that are not pregnant, breastfeeding, or likely to become pregnant within the next 6 months.
Exclusion: Patients with a complex atherosclerotic lesion such that withholding medication creates disproportionate risk; Women currently taking hormone replacement therapy; Patients with a bleeding disorder that would contraindicate the performance of a muscle biopsy, such as a history of clinically significant bleeding diathesis (i.e., Hemophilia A or B, Von Willebrand's Disease, or congenital Factor VII deficiency); Any other condition or event considered exclusionary by the PI and faculty physician.